What side effects are associated with this type of intervention?

Common treatments for obesity, such as GLP-1 receptor agonists (liraglutide, semaglutide), metformin, and orlistat, have various side effects. GLP-1 receptor agonists often cause gastrointestinal issues like nausea and vomiting. Metformin is associated with gastrointestinal discomfort, including diarrhea and nausea. Orlistat can lead to gastrointestinal side effects such as oily stools and flatulence. These medications are generally effective but require consideration of their side effect profiles when being prescribed.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity that focus on metabolic regulation and weight management. Notable among these are GLP-1 receptor agonists like liraglutide and semaglutide, which improve insulin sensitivity and glucose regulation while promoting weight loss. These drugs have shown efficacy in both weight management and glycemic control in patients with type 2 diabetes. Other approved medications include orlistat, which reduces fat absorption, and phentermine-topiramate, which suppresses appetite and enhances satiety. These treatments align with the mechanisms likely targeted by GSBR-1290, focusing on metabolic pathways to manage obesity and related metabolic disorders.

What other types of research exist?

Promising novel alternatives to GSBR-1290 for obesity treatment include: 1) SK0506, a Chinese herbal extract that reverses components of metabolic syndrome, particularly hyperlipidemia and visceral obesity. 2) BRL 26830A, a beta adrenoceptor agonist with antiobesity and antidiabetic properties, although it does not prevent weight gain long-term. 3) BRX-220, which has shown insulin-sensitizing action in high-fat diet-induced insulin resistance. 4) MR1704, a free fatty acid receptor 1 agonist that lowers blood glucose levels. 5) GSK256073, a GPR109A agonist that reduces serum glucose in type 2 diabetes mellitus patients. 6) JTT-501, an oral hypoglycemic agent that improves insulin resistance and hypertriglyceridemia.

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GSBR-1290 for Obesity and Type 2 Diabetes

Phase 1 & 2

Waitlist Available

Research Sponsored by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohorts 1-4: Age ≥ 18 and ≤ 75 years

Cohort 5: Treated with stable doses of ≥500 mg of metformin with a duration ≥6 months and at stable doses for ≥2 months with a screening HbA1c ≥7.0% and ≤10.5%

Must not have

Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval

A sitting BP after resting for 5 minutes > 160mm Hg systolic or > 100 mm Hg diastolic or an apical pulse rate <50 or >100 beats per minute

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new drug, GSBR-1290, in overweight/obese people and those with Type 2 Diabetes on Metformin. It aims to see if the drug is safe and how it affects the body, including its impact on blood sugar and weight.

Who is the study for?

This trial is for adults aged 18-75 who are overweight or obese with a BMI of 27-40 kg/m2, and those with Type 2 Diabetes Mellitus on stable metformin treatment. Participants should not use nicotine, have good venous access for blood sampling, and no significant health issues like heart or kidney disease.

What is being tested?

The study tests GSBR-1290's safety and effects compared to a placebo in overweight/obese individuals and those with Type 2 Diabetes over three months. It will look at how the body processes the drug (PK) and its impact on the body (PD).

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to drug ingredients, impacts on organ function as indicated by exclusion criteria such as liver test abnormalities, cardiovascular issues detected by ECG changes, or other systemic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have been on a stable dose of metformin (≥500 mg) for at least 6 months, with my HbA1c between 7.0% and 10.5%.

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I am between 18 and 75 years old.

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I am an adult with a BMI between 27 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart rhythm problems or abnormal ECG results.

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My blood pressure is high or my heart rate is too low or too high after resting.

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My liver tests are more than twice the normal limit.

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I have not had any major illnesses or surgeries in the last 3 months.

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My kidney function is reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 5Experimental Treatment2 Interventions

Participants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks

Group II: Cohort 4Experimental Treatment2 Interventions

HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks

Group III: Cohort 3Experimental Treatment2 Interventions

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Group IV: Cohort 2Experimental Treatment2 Interventions

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Group V: Cohort 1Experimental Treatment2 Interventions

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GSBR-1290

2023

Completed Phase 2

~160

Placebo

1995

Completed Phase 3

~2670

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as GLP-1 receptor agonists like liraglutide and semaglutide, work by mimicking gut hormones that regulate appetite and glucose metabolism. These drugs enhance insulin sensitivity, promote weight loss by reducing appetite, and improve glycemic control, which is particularly beneficial for patients with type 2 diabetes. The importance of these treatments lies in their ability to address both weight management and metabolic health, thereby reducing the risk of obesity-related complications such as cardiovascular disease and type 2 diabetes.

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